Overview

A Comparison of Ketamine Infusion Versus Placebo in Opioid Tolerant and Opioid Naive Patients After Spinal Fusion

Status:
Completed
Trial end date:
2017-09-01
Target enrollment:
0
Participant gender:
All
Summary
The aim of the proposed study is to examine the effectiveness of low dose postoperative ketamine infusion as an analgesic adjuvant to morphine pca in opioid tolerant and opioid naïve patients after major spine surgery. Primary endpoints of the study are to determine the effectiveness of postoperative ketamine infusion in for the reduction of postoperative pain and opioid requirements.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York University School of Medicine
NYU Langone Health
Treatments:
Ketamine
Criteria
Inclusion Criteria:

- Adult and teenage (>/=16) male or female who will undergo surgery for multilevel (>4
level) spinal fusion from a posterior approach with general anesthesia, and who are
fluent English speakers such that they can complete the pain score and satisfaction
questionnaires whose scores are a critical outcome variable.

- If female, subject is non-lactating and is either:

- Not of childbearing potential

- Of childbearing potential but is not pregnant at time of baseline as determined by
pre-surgical pregnancy testing.

- Subject is ASA physical status 1, 2, or 3.

Exclusion Criteria:

- anxiety

- psychiatric disorder

- Allergy or sensitivity to ketamine or dilaudid

- Deemed un-acceptable by study team

- Cognitively impaired (by history)

- Subject requires chronic antipsychotic medication

- Subject known to be in liver failure

- Subject for whom opioids or ketamine are contraindicated

- Patients with narrow angle glaucoma

- Patients with a history of psychosis